ALPROSTADIL

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ALPROSTADIL
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Infant Data

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MEDICAL INFORMATIONS

FDA APPROVED INDICATION

    To promote dilation of ductus arteriosus in infants with congenital heart disease dependent on ductal shunting for oxygenation/perfusion.

FDA APPROVED INDICATION

To promote dilation of ductus arteriosus in infants with congenital heart disease (ie, pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects) dependent on ductal shunting for oxygenation/perfusion. Low success rates for prostaglandin E1 are usually due to an irreversibly closed ductus and severe acidemia and collapse. Functional closure of the ductus occurs within a few hours of birth, and anatomical closure occurs in 21 days (normal term infant).

CONTRAINDICATIONS

None.

PRECAUTIONS

  • Cardiovascular:
    • Structural alterations (intimal lacerations, decreased medial muscularity, and disruption of the medial and internal elastic lamina) of the ductus and pulmonary arteries have been observed.
  • Gastrointestinal:
    • Gastric outlet obstruction due to antral hyperplasia may occur; dose- and duration-related.
  • Hematological:
  • Musculoskeletal:
    • Cortical proliferation of the long bones has been observed with long-term infusions; resolution with discontinuation of alprostadil.
  • Respiratory:
    • Do not use in neonates with respiratory distress syndrome.

ADVERSE EFFECTS

  • Common (6% to 15%): Apnea (consider treating with aminophylline), hypotension, fever, leukocytosis, cutaneous flushing, and bradycardia. Hypokalemia reported with long-term therapy (greater than 20 days), especially with doses greater than 0.05 mcg/kg/minute. Gastric outlet obstruction and reversible cortical proliferation of the long bones after prolonged treatment (greater than 120 hours).
  • Uncommon (1% to 5%): Seizures, hypoventilation, tachycardia, cardiac arrest, edema,sepsis, diarrhea, and disseminated intravascular coagulation.
  • Rare (less than 1%): Urticaria, bronchospasm, hemorrhage, hypoglycemia, and hypocalcemia.
  • Musculoskeletal changes: Widened fontanels, pretibial and soft tissue swelling, and swelling of the extremities may occur after 9 days of therapy. Cortical hyperostosis and periostitis may occur with long-term (greater than 3 months) therapy. These changes resolve over weeks after discontinuation of therapy.

BLACK BOX WARNING

Apnea has been reported in 10% to 12% of neonates with congenital heart defects treated treatment and be prepared to intubate/resuscitate.

ADMINISTRATION

Continuous infusion via a large vein is the preferred route of administration. May also be given via UAC positioned near the ductus arteriosus. For continuous infusion, dilute in compatible solution to a concentration of 2 to 20 mcg/mL. The recommended standard concentrations are 1, 2.5, 5, 10, and 20 mcg/mL for continuous infusions.

MONITORING

  • Thrapeutic: Restricted pulmonary blood flow: Improvement in blood oxygenation demonstrates efficacy. Restricted systemic blood flow: Improvement of systemic blood pressure and blood pH demonstrates efficacy.
  • Toxic:
    • Cardiovascular: Measure arterial pressure intermittently by umbilical artery catheter, auscultation, or with a Doppler transducer.
    • Gastrointestinal: Monitor for signs and symptoms of antral hyperplasia and gastric outlet obstruction in neonates administered alprostadil for more than 120 hours.
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